Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.
Plain-English summary
Cook Inc. is recalling five units of Torcon NB Advantage Catheters, identified by Lot Number NS9933622. The recall is due to a potential compromise of the sterility of the products caused by an undersealed chevron in the packaging pouches.
The affected catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures. The products were distributed worldwide, including in the United States and various international countries.
Healthcare facilities and users should stop using the affected lot and contact Cook Inc. for further instructions or replacement.
The recalled product
- Product
- Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 5
Distribution
Part of a larger recall action
This product is one of 71 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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